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A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions

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ClinicalTrials.gov Identifier: NCT02227732
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
CareFusion

Brief Summary:
The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusions Device: New Indwelling Pleural Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
New Indwelling Pleural Catheter Device: New Indwelling Pleural Catheter
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.




Primary Outcome Measures :
  1. Device -related safety and the number of adverse events. [ Time Frame: 28 days post catheter insertion ]

Secondary Outcome Measures :
  1. pleurodesis success [ Time Frame: 14 days ]
    Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.

  2. Pleurodesis success [ Time Frame: 28 days ]
    Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.

  3. pleurodesis success [ Time Frame: 60 days ]
    Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.


Other Outcome Measures:
  1. Breathlesness [ Time Frame: 14, 28, 60 days ]
  2. Chest Pain [ Time Frame: 14, 28, 60 days ]
  3. Time to pleurodesis [ Time Frame: 14, 28, 60 days ]
  4. Quality of Life [ Time Frame: 14, 28, 60 days ]
  5. Need for further pleural intervention post catheter removal [ Time Frame: 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥ 18 years old.
  2. Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:

    • There is histocytological confirmation of pleural malignancy
    • The effusion is an exudate (as per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
  3. Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
  4. Subject is willing and able to provide written informed consent.
  5. Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
  6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
  7. Negative pregnancy test if appropriate

Exclusion Criteria:

  1. Subject has significant trapped lung (>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung.
  2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3* or more.
  3. Subject is pregnant, planning to become pregnant, or is lactating.
  4. Subject has a history of empyema.
  5. Subject has a history of chylothorax.
  6. Subject has an uncorrected coagulopathy.
  7. Subject is allergic to device materials.
  8. Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.
  9. Subject has had a lobectomy or pneumonectomy on the side of the effusion.
  10. Subject has undergone a previous attempt at pleurodesis which has failed.
  11. Subject has previously been diagnosed with a serious immunodeficiency disorder.
  12. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than 1/3 of the hemithorax on chest x-ray).
  13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
  14. Subject has a mediastinal shift of ≥2cm toward the side of the effusion.
  15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.
  16. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated.
  17. Subject has no access to a telephone
  18. No details of blood values (full blood count, clotting screen, urea and electrolytes, liver function) from within the last 10 days * Patients who have a performance status of 3 may be considered for the trial if the removal of their fluid would likely improve their performance score by 1 or more.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227732


Locations
United Kingdom
Southmead Hospital - Academic Resporatory Unit
Westbury on Severn, Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
CareFusion

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT02227732     History of Changes
Other Study ID Numbers: CS-IS-VH-13-001
CI20130054 ( Other Identifier: UK MHRA )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms